{"id":104851,"date":"2025-06-17T10:36:03","date_gmt":"2025-06-17T08:36:03","guid":{"rendered":"https:\/\/www.pcb.ub.edu\/gate2brain-obtains-fda-orphan-drug-designation-for-its-drug-g2b-002\/"},"modified":"2025-06-17T11:34:01","modified_gmt":"2025-06-17T09:34:01","slug":"gate2brain-obtains-fda-orphan-drug-designation-for-its-drug-g2b-002","status":"publish","type":"post","link":"https:\/\/www.pcb.ub.edu\/en\/gate2brain-obtains-fda-orphan-drug-designation-for-its-drug-g2b-002\/","title":{"rendered":"Gate2Brain obtains FDA orphan drug designation for its drug G2B-002"},"content":{"rendered":"<p><strong>The biotechnology company <a href=\"https:\/\/www.pcb.ub.edu\/en\/empresa\/gate2brain-s-l\/\" target=\"_blank\" rel=\"noopener\">Gate2Brain<\/a>, headquartered at the Barcelona Science Park, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its lead candidate, G2B-002, an innovative therapy aimed at treating diffuse intrinsic pontine glioma (DIPG) and pediatric glioblastoma (pGBM), two of the most lethal pediatric brain tumors with very limited treatment options. This designation adds to the one granted by the European Medicines Agency (EMA) at the end of 2024 and underscores the significant potential of this therapy in both Europe and the United States.<\/strong><\/p>\n<p>The company, a spin-off from the University of Barcelona (<a href=\"https:\/\/web.ub.edu\/en\/home\" target=\"_blank\" rel=\"noopener\">UB<\/a>), the Institute for Research in Biomedicine (<a href=\"https:\/\/www.pcb.ub.edu\/en\/empresa\/institut-de-recerca-biomedica-irb-barcelona\/\" target=\"_blank\" rel=\"noopener\">IRB Barcelona<\/a>), and the Sant Joan de D\u00e9u Research Institute (<a href=\"https:\/\/www.irsjd.org\/en\/\" target=\"_blank\" rel=\"noopener\">IRSJD<\/a>) \u2013 Sant Joan de D\u00e9u Hospital (<a href=\"https:\/\/www.sjdhospitalbarcelona.org\/en\" target=\"_blank\" rel=\"noopener\">SJD<\/a>), specializes in the development of drug delivery systems across biological barriers. In this context, <a href=\"https:\/\/www.pcb.ub.edu\/en\/gate2brain-confirms-breakthrough-antibody-delivery-technology-to-the-brain-paving-the-way-for-next-generation-cns-therapies\/\" target=\"_blank\" rel=\"noopener\">its lead candidate, G2B-002<\/a>, enhances drug transport and penetration across the blood-brain barrier, increasing efficacy while minimizing systemic side effects.<\/p>\n<p>Endowed with this FDA designation, G2B-002 benefits from enhanced regulatory support and strategic momentum, smoothing its transition from advanced preclinical development into clinical trial phase.<\/p>\n<p>\u201cReceiving ODD from both the EMA and US FDA reaffirms our conviction in G2B-002\u2019s potential to address critical unmet needs in pediatric oncology,\u201d said <strong>Meritxell Teixid\u00f3<\/strong>, CEO &amp; CSO of Gate2Brain. \u201cThis dual recognition brings us a step closer to clinical trials and, ultimately, to offering new hope for young patients and their families.\u201d<\/p>\n<p>Gate2Brain remains dedicated to transforming the treatment landscape for pediatric brain tumors through innovative delivery solutions. The company has received support from institutions including Fundaci\u00f3n Bot\u00edn (Mind the Gap), Banco Sabadell (BStartup Health), CDTI (Neotec, Multipa\u00eds), the European Innovation Council (EIC Accelerator), Startup Capital d\u2019ACCI\u00d3 and CaixaResearch Consolidate de la \u201cFundaci\u00f3 la Caixa\u201d.<\/p>\n<p><strong>\u00bb Link to the news: <\/strong><a href=\"https:\/\/gate2brain.com\/gate2brain-obtains-fda-orphan-drug-designation-for-g2b-002\/\" target=\"_blank\" rel=\"noopener\">Gate2Brain website [+]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The biotechnology company Gate2Brain, headquartered at the Barcelona Science Park, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its lead candidate, G2B-002, an&#8230;<\/p>\n","protected":false},"author":14,"featured_media":104846,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[35],"tags":[306],"class_list":["post-104851","post","type-post","status-publish","format-standard","has-post-thumbnail","category-business","tag-gate2brain-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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